Breast implant ban, recall proposed by TGA

Australia’s medical device watchdog has recommended banning texture breast implants following an exhaustive review into their links to a rare form of cancer.

On Thursday, the Therapeutic Goods Administration (TGA) proposed cancelling, suspending and recalling a number of textured implant models over strong evidence that they were associated with a higher risk of anaplastic large cell lymphoma (ALCL).

The textured implants have been associated with an elevated risk of anaplastic large cell lymphoma (ALCL).

Five women in Australia and New Zealand have died of breast implant-associated (BIA) ALCL and 107 Australian women have been diagnosed with BIA ALCL.

All confirmed cases involved textured implants, according to an expert coalition of researchers and plastic surgeons led by Professor Anand Deva at Macquarie University's MQ Health.

The risk of BIA ALCL ranges between 1 in 1000 to 1 in 10,000 among women with most highly textured (grade 4 and grade 3) implants, the expert group estimates.

Globally, there have been 23 deaths and roughly 700 confirmed cases of BIA- ALCL.

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The TGA and expert group do not recommend the removal of textured implants in women who are not experiencing problems.

“If you have concerns about your breast implants, see your general practitioner and seek review by your surgeon.” Mr Hunt said.

Dr Dan Kennedy, vice president of the Australian Society of Plastic Surgeons said the message to the public was "don't panic".

"This should not invoke masses of people to think their implants need to be removed," he said.

"The risk [of ALCL] is low and in most instances the cancer can be managed in a straight-forward fashion and presents quite distinctly," he said.

The most common symptom is swelling caused by fluid build-up after the initial swelling immediately after surgery has subsided, and in some cases lumps in the breast or armpits.

The vast majority of BIA ALCL cases are cured by removing the implants and capsule surrounding them. Implants are not lifetime devices and need to be replaced after 10-15 years.

ALCL typically develops three to 14 years after breast implant surgery. It is not detectable on mammograms and is diagnosed from samples of fluid taken from around the implant.

Dr Kennedy recommended five-yearly checks for individuals with any type of breast implants, and more regular checks for those with highly textured models.

An estimated 40,000 Australian women undergo breast implant surgery every year after breast cancer mastectomy or for cosmetic enhancement.

Australian surgeons have predominantly used textured implants at significantly greater rates than many countries, including the US.

But Dr Kennedy said there has been a concerted shift away from textured implants in the last two years as the increasing evidence of their link to ALCL has emerged.

Though there was some concern among plastic surgeons that smooth implants did not offer the same aesthetically pleasing outcome, particularly for women who had undergone mastectomies, he said.

Australasian College of Cosmetic Surgery's BIA ALCL Safety Committee Chair Dr Daniel Fleming said Australians with textured implants should consider all of the evidence before taking any decisive action.

“There is no cause for alarm. The advice from the TGA and all experts in the field remains: there is no need to remove these implants as a precaution," said Dr Fleming, who was also a member of the expert group advising the TGA.

“The risk of developing BIA ALCL for those with textured breast implants remains very low and the risk of developing a cancer that spreads is extremely small.

"If patients do not have any symptoms, there is no need for any action because of this TGA announcement," he said.

Implant manufacturers have until July 24 to respond. the TGA's proposed regulatory action.

In a statement, Allergan said patient safety remained the company's highest priority and was reviewing the TGA's proposed regulatory action.

"Allergan continues to stand behind the benefit/risk profile of its breast implants," the statement read.

"With every medical procedure, there are benefits and risks, and Allergan continues to believe the benefit/risk profile of [Allergen's] textured breast implant products remains positive.”

Patients with questions or concerns should consult with their healthcare professional and can also contact Allergan’s at medinfo.australia@allergan.com or 1800 252 224.